The positive results are from a phase II study where a statistically significant proportion of patients on active treatment obtained a 20% improvement of the American College of Rheumatology (ACR) response compared to patients treated with placebo.
Genmab commented that rates of overall adverse events were comparable between the groups of patients receiving HuMax-CD20 these were primarily infusion related and do not limit plans for continued development.
Genmab expects that phase III studies will begin in 2007.
“The interim data are comparable to the phase I/II rheumatoid arthritis data trial released earlier this year and support our plan to move into phase III with HuMax-CD20 in rheumatoid arthritis,” said Lisa Drakeman, CEO of Genmab.